A major problem facing the health care industry today is the difficulty of enforcing patient compliance with prescription and health care regimens and therapies. All too often, patients ignore the directions associated with their prescriptions, consuming more or fewer pills than recommended by their doctor. Many patients simply forget to take the medication for one or more days, resulting in a lengthened healing process. Adherence to prescriptions for the treatment of asymptomatic conditions is particularly troublesome. Without being reminded of the long-term benefits of a treatment, for example, patients may stop taking a medication when no immediate benefit is apparent (e.g., decreased pain or remediation of another obvious symptom).
In some cases not taking pills according to a precise schedule can result in complications requiring expensive hospital stays or increased time consulting with a physician. Patients taking lipid-lowering medications (e.g., to lower cholesterol) may, for example, experience “excess morbidity and mortality” due to noncompliance with prescription regimens. Jacobsen, Terry A., M.D., “The Forgotten Risk Factor: Noncompliance With Lipid-Lowering Therapy”, Medscape® Cardiology, www.medscape.com/viewarticle/496144, posted Dec. 22, 2004, at pg. 7.
Indeed, recent studies have shown that as little as forty to fifty percent (40-50%) of patients taking 3-hydroxymethylglutaryl-coenzyme inhibitors (“statins”; e.g., Lipitor®) to lower cholesterol were adhering to their prescriptions after just six (6) months. See, Benner, Joshua S, et al., “Association between short-term effectiveness of statins and long-term adherence to lipid-lowering therapy”, Am J Health-Syst Pharm—Vol 62, Jul. 15, 2005. The additional costs due to such noncompliance are passed on to health care providers and insurers. Estimates are that such costs may be in excess of one hundred billion dollars ($100 billion) per year. Jacobsen, at pg. 1.
Efforts to promote increased compliance with health care prescriptions and therapies include “[u]sing a warm and caring tone featuring more positive than negative words,” reducing the complexity of treatment regimens, following up with patients that miss appointments, providing e-mail reminders to patients, increasing patient education, and providing reminder, cognitive, and/or self-monitoring aids. Jacobsen, at pg. 6. Such basic tactics have, however, “proved to be complex, labor intensive, and of unreliable effectiveness.” Id., at pg. 5. More advanced approaches and methods have also been presented.
One such approach to solving the problem of patient compliance has been the development of modified pill containers that automatically dispense the correct number of pills. U.S. Pat. No. 5,641,091 to Daneshvar describes a medication-dispensing device that allows a patient to receive his medication on a regular basis. A series of small spaces are arranged in one or more electrically powered rotating trays to allow a proper dose via a window. While this approach makes it easier for a conscientious patient to follow his prescription, forgetful patients may simply let pills “build up” rather than consuming them. Additionally, such devices contain many moving parts that are subject to malfunction and wear. Malfunctions could result in legal liability if the patient was provided access to fewer pills than required by his prescription.
A similar dispensing device is described in U.S. Pat. No. 5,472,113 to Shaw. The automatic pill-dispensing device of Shaw has cartridges rotated via an electric motor, electromagnetic clutches, a rotatable shaft, and gears. As with the Daneshvar device, there is no way for a remote third party to know whether or not the device is operating properly and whether the patient is in fact complying with his prescription.
Because third parties such as hospitals and insurance companies would like to have access to patient prescription compliance data, other devices have been created to store data such as how often a pill container has been opened or the time and date that it was opened. U.S. Pat. No. 5,016,172 to Dessertine and U.S. Pat. No. 4,939,705 to Hamilton et al. both describe such an apparatus. These devices, however, either require the user to physically deliver the apparatus to the interested third party for data retrieval and verification, or require that the device have a modem for online connection to the third party. Physical delivery is time consuming and potentially costly for the user, while an online connection requires expensive hardware and greater sophistication on the part of the user.
A need therefore exists for systems, apparatus, methods, and articles of manufacture that address these and other deficiencies of the prior art. A need exists, for example, for securely measuring, reporting, and tracking patient compliance in an off-line environment. A need also exists for facilitating improved patient compliance with health care regimens.